Rhinitis is produced by irritation and inflammation of the mucous membranes of the nasal cavities and is generally caused by allergic reactions, environmental irritants, bacteria and/or viruses. Symptoms of rhinitis include ninny nose, nasal congestion and post-nasal drip. Rhinitis has been associated not only with discomfort, congestion and nasal conditions, but also sleeping problems, ear conditions and learning challenges. Treatment generally involves administration of antihistamines, leukotriene antagonists, nasal corticosteroids, decongestants, allergen immunotherapies, or saline irrigation of sinus cavities.
Sinusitis is produced by a number of pathologic processes, including inflammation of the sinus cavities, poor mucus transport, obstruction of passages from inflammatory debris and growth of biofilms within the sinuses and their drainage systems (ostea). Additionally, resulting stagnation, edema and poor blood flow in the surrounding tissue further decreases the ability of blood borne assistance in the form of immune modulators and antibiotics to reach the site. Microorganisms encased in biofilms are notoriously difficult to treat, since the biofilm matrix is highly resistant both to the action of the immune system and to treatment with antibiotics. Sinusitis therapy may involve saline irrigation and administration of aerosols, as well as the administration of drugs such as antibiotics, decongestants, antihistamines and nasal steroids, sinus surgery, balloon sinuplasty and administration of nebulized antibiotics. Response rates for current therapies are generally relatively low, both on a short term and a long term basis. This is likely because of the multifactorial nature of this disease as described above. Each individual therapy used as standard treatment for sinusitis does not address all pathophysiologic causes that accumulate to cause the disease, sinusitis. This is true for other diseases such as chronic ear infections, recurrent skin infections, chronic wounds, vascular plaques, gastroenterologic obstructions and solid tumors.
Nasal irrigators for application of both solutions and aerosols are well known and are used to relieve symptoms of sinusitis and rhinitis, such as nasal congestion. Routine nasal irrigation generally improves symptoms in adults with chronic rhinosinusitis, as well as children with allergic rhinitis. Irrigating fluid, such as saline, may improve nasal ciliary motility and may additionally reduce airway edema and soften the mucus, which allows more effective aspiration. Irrigation and aspiration, or suctioning, is typically performed in hospital or medical office environments using installed, wall suction systems that are quite powerful and can be quite effective. Manual irrigating and/or aspirating devices that are available for home use are generally low flow rate, low aspiration pressure devices. Neti pots and squeeze bottles, for example, are used to irrigate nasal passageways manually and, while they temporarily relieve symptoms, they provide little long term comfort.
US 2008/0154183 A1 discloses self-contained, motorized devices that provide continuous or intermittent suction, as well as continuous or intermittent, on-demand delivery of irrigating fluid to nasal passages. US 2009/0281454 A1, 2009/0281482 A1, 2009/0281483 A1 and 2009/0281485 A1 disclose additional features of irrigation and aspiration devices. The disclosures of these patent publications are incorporated herein by reference in their entireties.
Commercial devices provide pulsed mist and/or a pulsating rinse to nasal passages using misting wands. Recent product improvements include a flex tip allowing 360° rotation with a tip locking and release feature, variable, stepless pressure control and a calibrated pulse rate. Different wands may be provided for the pulsed mist and pulsating rinse modes.
Delivery of liquid rinses and mists to nasal passages is described in the patent literature. US 2007/0299396 A1 discloses a pulsatile irrigation device producing a calibrated pulsatile rinse of 1200-1250 pulses/min, driven by a piston driven pump assembly. Atomization to droplets of about 15-25 microns is accomplished using a bolt encased in the end of the tip. U.S. Pat. Nos. 4,776,990, 4,805,614 and WO 2007/129297 disclose devices for home and office use that provide water-saturated, pressurized, heated air to nasal passages.
Many different types of nebulizers and aerosol generators have been developed. Some devices employ ultrasound transducers to nebulize solutions or generate aerosol droplets. U.S. Pat. No. 3,774,602, for example, discloses a disposable, cartridge-type single shot ultrasonic nebulizer for inhalation therapy. U.S. Pat. No. 4,109,863 discloses another apparatus for ultrasonic nebulization of liquid samples or suspensions. U.S. Pat. No. 4,319,144 discloses a nebulization control system for a piezoelectric ultrasonic nebulizer. U.S. Pat. No. 6,357,671 discloses another ultrasonic nebulizer that is controllable to vary the amplitude of the ultrasonic output.
Liquid aerosols may also be produced using micropumps, including electronic micropumps. In one system, a dome-shaped aperture plate or diaphragm having many tapered holes is vibrated at a high rate (e.g., 100,000 times per second). The rapid vibration causes each aperture to act as a micropump, drawing liquid through the holes and ejecting consistently sized droplets.
Liquid projection apparatus having addressable nozzles are also known. U.S. Pat. No. 6,394,363 discloses a device having multiple transducers associated with multiple nozzles for projecting liquid as jets or droplets from selected nozzles. Related liquid projection apparatus are described in PCT International Publications WO 2008/044069 A1, WO 2008/044070 A1, WO 2008/0044071 A1, WO 2008/0044072 A1 and WO 2008/0044073 A1.
Application of ultrasound directly or indirectly to the nasal passages, or to tissue in the nasal passages, has also been proposed. Experimental studies administering low intensity (1 W/cm2), pulsed (1:9) and continuous therapeutic ultrasound at a frequency of 1 MHz to sinuses by application of an ultrasound soundhead to the skin of the cheeks and forehead were conducted to ascertain the effect on chronic sinusitis and chronic rhinosinusitis. Ansari et al., Therapeutic ultrasound as a treatment for chronic sinusitis, Physiotherapy Research International, 9(3) 144-146 (2004); Ansari et al., Physiotherapy for chronic rhinosinusitis: The use of continuous ultrasound, International Journal of Therapy and Rehabilitation, July 2007, Vol. 14, No. 7; Ansari et al., A preliminary study into the effect of low-intensity pulsed ultrasound on chronic maxillary and frontal sinusitis, Physiotherapy Theory and Practice, 23(4):211-218, 2007.
The use of high intensity focused ultrasound (e.g., HIFU) is well known for ablation or remodeling of various types of tissue. Ultrasound catheter systems for delivering ultrasound energy for ablating obstructions within blood vessels using an ultrasound transmission wire or ultrasound transmission member are described, for example, in U.S. Pat. Nos. 7,297,131 and 5,989,208.
A handheld, focused ultrasonic therapeutic device for treating skin lesions involved with gynecological disorders is described in US 2005/0080359. A supersound treatment apparatus suitable for treatment of rhinitis is described in PCT International Patent Publication WO 2008/009186. Devices targeting ultrasound beams on subepithelial layers of nasal mucosa in the nasal turbinates have been reported to reduce the volume of inferior turbinates, while increasing the volume of nasal ventilation.
US 2008/0027423 discloses a system for treatment of nasal tissue by application of ultrasound energy directly to tissue regions beneath the surface of the turbinate tissue. Fluid may be infused or injected directly into the turbinate tissue being treated, e.g. to enlarge the size of the turbinates and ensure delivery of ultrasound energy directly to the tissue. U.S. Patent Publications 2007/0244529 and 2008/0027423 relate to injecting fluid into the nasal turbinate using retractable needles at the end of a wand and then delivering ultrasound energy into the turbinate tissue. The treatment is accomplished using frequencies of from 0.5 to 12 MHz, generally from 5 to 12 MHz. Cooling fluid and/or radio frequency (RF) energy may also be delivered from the ultrasound and infusion probe.
Other modalities, including surgical techniques, are also used for treating tissue in intranasal passages. Somnoplasty uses controlled, low-power radiofrequency energy to create one or several submucosal volumetric lesions, which are resorbed over a period of several weeks to reduce unwanted tissue volume and stiffen remaining tissue in desired areas. Electrosurgical techniques are used for ablating, shrinking, coagulating or otherwise modifying tissue, including enlarged or hypertrophied nasal turbinates. In some systems, an active electrode of an electrosurgical probe is positioned in proximity to target tissue in the presence of an electrically conductive fluid. When a high frequency voltage is applied, tissue in proximity to the electrode is ablated, severed, or modified. Endoscopic techniques such as balloon sinuplasty, in which a sinus balloon catheter is positioned across a blocked ostium and inflated to restructure the blocked ostium, are also used for opening blocked passageways. Placement of stents and other implantable devices in sinus passageways is also performed to maintain patency.
Rhinitis and sinusitis remain widespread throughout many populations despite the many devices and systems described in the prior art. Effective and long-lasting reduction of mucus and accumulated inflammatory debris and reduction in the growth of biofilms within the nasal passages, sinuses and their drainage systems, remain challenging despite the proliferation of treatment options. There is a basis for using both saline and ultrasound individually for the treatment of nasal congestion, chronic sinusitis and chronic wounds. The disclosure presented herein is directed, in part, to providing improved methods and systems for delivery of fluids and aerosols and ultrasound energy to tissue surfaces, cavities and obstructed sites in passages, lumens or cavities such as nasal passages, sinuses and sinus ostia.